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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceImplantable System for Remodulin (ISR)
Generic NamePump, infusion, implanted, programmable
ApplicantMedtronic, Inc.
710 MEDTRONIC PARKWAY NE
MINNEAPOLIS, MN 55432-5604
PMA NumberP140032
Supplement NumberS049
Date Received01/17/2020
Decision Date11/10/2020
Withdrawal Date 08/18/2021
Product Code LKK 
Advisory Committee General Hospital
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for change of a new sterile packaging (sterile pack) sealing equipment. This change applies to the Refill Kits, Catheter Access Port (CAP) Kit and Catheter Patency Kit in use with the SynchroMed Infusion System Ascenda Intrathecal catheter and Implantable System for remodulin.
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